The AIA ushered in significant changes in the patent system. At the time, there was much consternation about the change to a first-inventor-to-file system. The prospect of enhanced post-grant challenges was an afterthought, dismissed as a variation in inter partes reexamination. Inter partes reexamination filings even spiked in 2012, as practitioners were reluctant to let go of the familiar process in favor of the new post-grant trial system.
In the last two weeks, the PTAB has invalidated three patents covering Copaxone®, a multiple sclerosis drug marketed by Teva with annual sales of over $3 billion. Challenged by generic manufacturers Mylan and Amneal, the patents specifically covered a long-acting form of Copaxone®, known as “3-times-a-week COPAXONE® 40 mg/ml,” which Teva developed when the original version of Copaxone® was coming off patent protection.
These IPR decisions highlight the usefulness of post-grant proceedings for generic and biosimilar manufacturers, particularly for challenging follow-on patents, such as those covering specific dose regimens, as we discussed in earlier posts.
The Federal Circuit seemingly had put to rest the question of whether, in making an amendment in an IPR, the petitioner bears the burden of proving an amended claim unpatentable or the patent owner bears the burden of proving the amended claim patentable. Microsoft Corp. v. Proxyconn, Inc. upheld PTAB procedures placing the burden on the patent owner to prove patentability. Other CAFC panels—including Prolitec, Inc. v. ScentAir Techs., Inc. and Nike, Inc. v. Adidas AG—followed. Currently, claim amendments are evaluated in accordance with the PTAB’s guidance in Idle Free Systems, Inc. v. Bergstrom, Inc. and MasterImage 3D, Inc. v. RealD Inc. As set out in these cases, the patent owner must prove patentability over prior art of record, which includes the prior art cited in the original prosecution of the challenged patent, as well as prior art that the patent owner should put on the record in accordance with its duty of candor.
Institution decisions at the Board are rarely changed, and cannot be appealed. Following institution, the timeline for trial is fast and unforgiving. But what happens when the Board leaves its institution decision open to modification in the future? This is the scenario playing out in an ongoing IPR trial.
Despite black-letter law that IPRs can only resolve patentability based on prior art patents and printed publications, enablement and written description support can be key issues, particularly in life sciences patents with functional antibody claims. A final written decision in Daiichi Sankyo Company Limited v. Alethia Biotherapeutics, Inc. (IPR2015-00291) found such claims unpatentable after finding that the priority application failed to pass muster from a § 112 standpoint, but that the invention was disclosed in a reference published after the priority document was filed but before the filing of the continuation-in-part that was challenged.
Intex, a swimming pool manufacturer, challenged its competitor’s air purge valve patent by petitioning for IPR. The Board instituted trial, despite Bestway, the patent owner, raising questions about whether some of the references asserted in the petition were prior art that could be relied on in IPR.
The CAFC has recently focused attention on the use of functional claim language—that is, claim language that describes what an element does, rather than describing what the element is. A recent IPR showed how functional claiming can play out at the PTAB, where it is often the case that neither the petitioner nor the patent owner wants the claims to be construed as employing “means-plus-function” language. For the petitioner, such an interpretation would make it more difficult to show invalidity. For the patent owner, such an interpretation could substantially narrow the scope of the claim and have a significant downstream impact on the patent owner’s ability to show infringement. But the PTAB may have its own ideas about how to interpret the claims.
The U.S. Supreme Court today issued what had the potential for being the most significant case to impact one of the most significant additions to patent law in our lifetimes. At issue in Cuozzo Speed Technologies, LLC v. Lee was the way the Patent Office’s Patent Trial and Appeal Board (PTAB) and the courts have been dealing with a new type of challenge to patents, made available in the fall of 2012 under the America Invents Act (AIA). AIA trials have been sought over 5,000 times to challenge patents and are widely used to resolve patent disputes. Many patent owners complained that these proceedings were unfairly tilted in favor of those challenging patents. Cuozzo sought Supreme Court review of two such practices that it felt went too far and were inappropriate given the language and intent of the AIA. However, the Court sided with the PTAB on both issues, leaving the AIA trial process, as practitioners have come to know it over the last four years, intact.
Multiple IPRs challenging patents covering brand-name biologics have now been filed by biosimilar developers, for reasons we recently discussed, as well as by other entities. Institution decisions in these early IPRs and a small number of final written decisions suggest that broad mechanistic claims as well as follow-on patent claims—such as those covering methods of treating specific patient populations or specific dose regimens—will be vulnerable to obviousness challenges at the PTAB. However, a tougher time should be expected in challenging composition-of-matter patents.
Last month, the Board weighed in on what it means to be human in a rare decision granting a motion to amend claims in an IPR (IPR2015-00208). The owner of U.S. Patent No. 6,681,897 (which covers a method of handling a wheel of an elevated vehicle to avoid injury) proposed claims in its motion to amend that narrowed the original claims in a number of ways. One addition was to explicitly use the term “human” in referring to who performs the steps of the claims, an addition that may not have been intended to invite deep philosophical discourse. Rather, the patent owner apparently intended to distinguish from the art by excluding methods in which the weight of the wheel is partially supported by a non-human entity, like a hoist, during a carrying step.